By the end of September 2017, the company plans to launch Exalgo
32mg extended release tablets (hydromorphone HCl) in the US market.
This supplemental new drug application (sNDA) for the 32 mg dose strength of EXALGO
was filed by Mallinckrodt Inc, which acquired its rights in June 2009.
CombinatoRx has the potential to create a thriving biopharmaceutical business based on the nearer-term revenue-generating potential of our partnered product assets, such as Exalgo
and Prednisporin, while focusing internal efforts on key programs in our product pipeline with the highest likelihood of creating value going forward.
The indication for Exalgo
(available in 8-, 12-and 16-mg tablets) is once-daily administration for the management of moderate to severe pain in opioid-tolerant patients requiring round-the-clock opioid analgesia for an extended period.
At the meeting, efficacy and safety data and details of the Risk Evaluation and Mitigation Strategies (REMS) for Exalgo
were presented by officials from Neuromed Pharmaceuticals and Covidien, which has acquired the U.
Covidien said Exalgo
recently met its goal in a late stage clinical trial, and the Food and Drug Administration is scheduled to rule on the drug's approval by Nov.
Under terms of the deal, Mallinckrodt has agreed to grant Watson a licence to US patents relating to Exalgo
without the payment of any royalties.
The panel was not asked whether to recommend approval of the drug, but agreed that Exalgo
appeared to be effective for chronic pain, based on data from a trial in chronic back pain patients.
Watson said it believes it may be a "first applicant" to file an ANDA for the 8 mg, 12 mg, and 16 mg generic versions of Exalgo
and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
26 April 2010 - Ireland-based and US-listed healthcare company Covidien Plc (NYSE: COV) introducedaA today EXALGO
(hydromorphone HCI) Extended-Release Tablets, (CII), the only extended-release hydromorphone treatment available in the USA.
Covidien has updated its sales guidanceaA for the entire fiscal 2009/10aA aA to reflect the recent strengthening of the US dollar against most currencies, the approval of EXALGO
, the sale of the US nuclear pharmacies, coupled with weakness in certain product lines.